1. Long-term cardiovascular safety of febuxostat compared with allopurinol in patients with gout (FAST):a multicentre, prospective, randomised, open-label, non-inferiority trial
- Author
-
Isla S Mackenzie, Ian Ford, George Nuki, Jesper Hallas, Christopher J Hawkey, John Webster, Stuart H Ralston, Matthew Walters, Michele Robertson, Raffaele De Caterina, Evelyn Findlay, Fernando Perez-Ruiz, John J V McMurray, Thomas M MacDonald, J. Aziz, G. Dobson, A.S.F. Doney, R.W.V. Flynn, J. Furnace, J.W.K. Grieve, G. Guthrie, D. Jamieson, C.G. Jennings, S. Kean, L.C. Lund, A. McConnachie, F. Pigazzani, P.L. Riches, M. Rix Hanson, A Rogers, E.D.M. Rooke, J. Thomson, M. Warren, K. Wetherall, R. Wilson, C.P. Hall, A. Maseri, H.A. Bird, G. Murray, J.W. Dear, M. Petrie, M. MacDonald, P.S. Jhund, E. Connolly, D.J. Murphy, N. Paul, A. Olsson, P.T. Koskinen, A. Fuat, A. Foster, W. Saywood, R.J. Barr, L. McConnachie, L.F. Wilson, L. Larsen Rasmussen, A.R. McGinnis, H. Birrell, M. Keiller, I.S. Bremner, G.J. Forbes, J.S. Dumbleton, J. Rhodes, and T. Waller
- Subjects
medicine.medical_specialty ,business.industry ,Allopurinol ,General Medicine ,030204 cardiovascular system & hematology ,medicine.disease ,Gout ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Clinical endpoint ,030212 general & internal medicine ,Febuxostat ,Risk factor ,business ,Prospective cohort study ,Adverse effect ,medicine.drug - Abstract
Background:\ud Febuxostat and allopurinol are urate-lowering therapies used to treat patients with gout. Following concerns about the cardiovascular safety of febuxostat, the European Medicines Agency recommended a post-licensing study assessing the cardiovascular safety of febuxostat compared with allopurinol.\ud \ud Methods:\ud We did a prospective, randomised, open-label, blinded-endpoint, non-inferiority trial of febuxostat versus allopurinol in patients with gout in the UK, Denmark, and Sweden. Eligible patients were 60 years or older, already receiving allopurinol, and had at least one additional cardiovascular risk factor. Those who had myocardial infarction or stroke in the previous 6 months or who had severe congestive heart failure or severe renal impairment were excluded. After a lead-in phase in which allopurinol dose was optimised towards achieving a serum urate concentration of less than 0·357 mmol/L (
- Published
- 2020
- Full Text
- View/download PDF